Validation Engineer

Katalyst CRO; Irvine (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

Katalyst CRO in Irvine, California is seeking a Validation Engineer to support product validation in a regulated medical device environment. The role involves leading Continuous Improvement initiatives, collaborating with teams to enhance product performance, and ensuring compliance with regulatory standards. Candidates should have a Bachelor's degree in engineering and 3-5 years of relevant experience, along with strong project management skills. Proficiency in Microsoft Project is a plus.

Qualifications

• 3-5 years of experience in validation engineering or related fields.
• Strong understanding of validation processes and engineering documentation.
• Experience in medical device environments is preferred.

Responsibilities

• Lead Continuous Improvement projects and collaborate with internal teams.
• Conduct engineering testing and develop test protocols.
• Prepare project budgets and manage timelines and dependencies.

Skills

Continuous Improvement (CIP)

Project management

Electrical design understanding

Cost-benefit analysis

Engineering testing

Education

Bachelor's degree in Electrical Engineering, Mechanical Engineering, Software Engineering or related discipline

Tools

Microsoft Project

PowerPoint

Job description

Job Summary

The Validation Engineer will work under limited supervision to support product validation and engineering activities in a regulated medical device environment. The role focuses on leading Continuous Improvement (CIP) initiatives, supporting process validation, and ensuring compliance with applicable regulatory standards. The engineer will collaborate with internal teams and external suppliers to improve product performance, reduce costs, and ensure robust validation of systems and processes, including those related to product electrical design and functionality.

Roles & Responsibilities

• Lead Continuous Improvement (CIP) projects in collaboration with cross‑functional internal teams and external suppliers.
• Perform CIP calculations, including supplier quotation evaluations and cost‑benefit analysis.
• Develop and manage project budgets covering feasibility studies, capital equipment, validation costs, DVT samples, and related testing requirements (e.g., bioburden).
• Create detailed project plans using Microsoft Project and prepare presentation materials using PowerPoint.
• Demonstrate understanding of product electrical design, system architecture, and functional performance.
• Lead design changes, component substitutions, and supplier transitions to achieve cost savings and improved performance (Type II savings).
• Develop strategies to meet CIP targets and drive continuous improvement initiatives.
• Conduct engineering testing, develop test protocols, prepare test reports, and participate in design reviews.
• Oversee project execution including timelines, dependencies, and task coordination.
• Identify appropriate electrical test methods and collaborate with R&D teams to align requirements.
• Review engineering requirements, support process validation activities, and finalize validation documentation (e.g., RR forms, validation reports).
• Execute change control processes and supplier change requests.
• Communicate technical issues, risks, and opportunities to management.
• Ensure compliance with Health, Safety, Environmental, and regulatory requirements.
• Maintain adherence to federal, state, local, and company procedures.
• Provide technical guidance or supervision to junior engineers or technicians as needed.

Education & Experience

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, Software Engineering, or related Engineering discipline.
• 3-5 years of relevant experience in validation engineering, product engineering, or manufacturing engineering within a regulated industry.
• Experience in medical device or similarly regulated environments preferred.
• Strong understanding of validation processes, process engineering, and engineering documentation.
• Experience with Continuous Improvement (CIP), supplier coordination, and project execution is highly desirable.
• Familiarity with product design, electrical systems, and engineering test methods is preferred.
• Proficiency in Microsoft Project and PowerPoint is an added advantage.
• Strong knowledge of regulatory requirements and quality systems in a manufacturing environment.